Abstract
Introduction
Optimal orthopaedic implant placement is a major contributing factor to the long term success of all common joint arthroplasty procedures. Devices such as 3D printed bespoke guides and orthopaedic robots are extensively described in the literature and have been shown to enhance prosthesis placement accuracy. These technologies have significant drawbacks such as logistical and temporal inefficiency, high cost, cumbersome nature and difficult theatre integration. A radically new disruptive technology for the rapid intraoperative production of patient specific instrumentation that obviates all disadvantages of current technologies is presented.
Methods
An ex-vivo validation and accuracy study was carried out using the example of placing the glenoid component in a shoulder arthroplasty procedure.
The technology comprises a re-usable table side machine, bespoke software and a disposable element comprising a region of standard geometry and a body of mouldable material.
Anatomical data from 10 human scapulae CT scans was collected and in each case the optimal glenoid guidewire position was digitally planned and recorded.
The glenoids were isolated and concurrently 3D printed. In our control group, guide wires were manually inserted into 1 of each pair of unique glenoid models according to a surgeon's interpretation of the optimal position from the anatomy. The same surgeon used the guidance system and associated method to insert a guide wire into the second glenoid model of the pair.
Achieved accuracy compared to the pre-operative bespoke plan was measured in all glenoids in both the conventional group and the guided group.
Results
The technology was successfully able to intraoperatively produce sterile, patient specific guides according to a pre-operative plan in 5 minutes including device set up and planning, at a minimal cost. In the manual insertion group, average accuracy achieved was 6.8° and 1.58mm with respect to the plan compared to the guided group where an average of 0.74mm and 1.72 ° was achieved.